Introduction -

In many ways, 2019 was a notable year for biosimilars in the U.S. FDA approved the 26th biosimilar product and the 13th biosimilar product was launched in the U.S. market. These developments were accompanied by a flurry of activity at FDA, new proposed and enacted legislation, and new developments in court and in post-grant proceedings. Below, we review the developments in the field in terms of biosimilar approvals and launches, FDA guidance on biosimilars, pending biosimilar legislation, litigation under the Biosimilars Price Competition and Innovation Act (BPCIA), litigation related to alleged anticompetitive behavior on the part of reference product sponsors, and biologic-related post-grant challenges.